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NCT00525382 Clinical Trial

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

Urticaria Clinical Trial

Official title:
A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00525382
Other study ID # A00334
Secondary ID
Status Completed
Phase Phase 3
First received September 4, 2007
Last updated December 11, 2013
Start date August 2003
Est. completion date March 2004

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority China: Department of Health, Pharmaceuticals registration and Import/Export control section
Study type Interventional

Clinical Trial Summary

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date March 2004
Est. primary completion date March 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Male or female, 18 to 60 years old (inclusive

- having chronic idiopathic urticaria

- at least 6-weeks history of CIU, had at least 3 days of wheals presence/week

- moderate to severe CIU defined as pruritus score = 2, number of wheals = 2, and total symptoms CIU score = 2 at randomization

Exclusion Criteria:

- Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn

- atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids

- urticaria caused by physical factors or other known factors

- cholinergic urticaria

- had urticaria due to other systemic disorders

- were on antihistamine drug currently

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• levocetirizine dihydrochloride

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary pruritus severity, assessed by the investigator over 2 weeks of treatment 2 weeks
Secondary Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety 2 weeks
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